VITROS HBeAg

Page Type

PMA Approval

PDF

* The FDA doesn't provide PDFs for all submissions.

Applicant

Ortho-Clinical Diagnostics, Inc.

Trade Name

VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK/PRODUCTS HBEAG CALIBRATOR/PRODUCTS HBE CONTROLS

Generic Name

Test, hepatitis b (b core, be antigen, be antibody, b core igm)

Decision Date

5/11/2011

Days to Decision

511 days

Decision Code

APPR

FDA Decision

Approval

FDA Browser

VITROS HBeAg

Page Type: PMA Approval
PDF: PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant: Ortho-Clinical Diagnostics, Inc.
Trade Name: VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK/PRODUCTS HBEAG CALIBRATOR/PRODUCTS HBE CONTROLS
Generic Name: Test, hepatitis b (b core, be antigen, be antibody, b core igm)
Decision Date: 5/11/2011
Days to Decision: 511 days
Decision Code: APPR
FDA Decision: Approval